LevineConservationModelandColorectalPatients

NCT ID: NCT06499129

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2025-12-28

Brief Summary

Colorectal cancer is one of the most common types of cancer in the world, ranking 3rd among cancers that cause death in men and women. In patients diagnosed with colorectal cancer, chemotherapy treatment is planned to prolong survival as in all other cancer patients. Among the side effects of chemotherapy treatment, it is known that fatigue develops between 50-90%, which is mild for one week in 45% of patients and persists for two weeks in 33%. In the literature, the incidence of chemotherapy-induced peripheral neuropathy is reported to be between 10-100% depending on the type and dose of the drug taken. Alejandro et al. (2013) reported that the incidence of oxaliplatin-related peripheral neuropathy was 84%, which was acute in 74% of patients and permanent in 48%. In addition, anxiety disorders are among the common mental symptoms in cancer patients and their prevalence has been reported to be 10-30%.

In this study, it is aimed to reveal the effect of nursing interventions based on Levine's Conservation Model on fatigue, peripheral neuropathy and anxiety levels in colorectal cancer patients receiving chemotherapy treatment.

Conditions

Fatigue; Peripheral Neuropathy; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

SensoryBall

The training content prepared based on the Levine Conservation Model will be given to patients assigned to the intervention group. Training content information in line with the Levine Conservation Model; The conservation model, which is the application of nursing theoretical knowledge for practice, will focus on the applications to be made for three basic principles for the protection of energy, protection of structural integrity and protection of personal integrity.

Soft plastic sensory balls for hands and feet will be used in the management of peripheral neuropathy symptom.

In the sensory exercise for the feet, the patient will be asked to place the foot sensory ball between the floor and the foot and roll it to create a slight pressure on the sole of the foot.

Progressive Relaxation Exercises Practice Progressive relaxation exercises will be played to colorectal cancer patients who will receive chemotherapy.

Group Type: EXPERIMENTAL

Sensory ball, progressive relaxation exercise, training

Intervention Type: BEHAVIORAL

The effect of sensory ball use on fatigue, peripheral neuropathy and anxiety will be examined

Control

The control group patients who will receive chemotherapy treatment for the first time and who meet the inclusion criteria will not receive any intervention other than standard chemotherapy treatment and standard nursing care and will be asked to complete the Personal Information Form (only on the first day), Cancer Fatigue Scale, CIPNAT and Trait Anxiety Inventory on the first chemotherapy day, 14th day and 28th day.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sensory ball, progressive relaxation exercise, training

The effect of sensory ball use on fatigue, peripheral neuropathy and anxiety will be examined

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Between the ages of 18-75
• Diagnosed with primary and new colorectal cancer (Stage II and III),
• The decision to start the FOLFOX treatment protocol has been taken,
• Having a smartphone,
• Being literate,
• Ability to speak and understand Turkish,
• Open to communication and cooperation.

Exclusion Criteria

• History of neuropathy or diabetes,
• History of hypothyroidism, renal failure,
• Hearing, speech and vision problems,
• Receiving radiotherapy or immunotherapy,
• Psychiatric diagnosis or ongoing treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Necmettin Erbakan University

OTHER

Sponsor Role: collaborator

KTO Karatay University

OTHER

Sponsor Role: lead

Responsible Party

Naciye Esra Koyuncu

Researcher Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naciye Esra koyuncu

Role: STUDY_CHAIR

NECMETTİN ERBAKAN ÜNİVERSİTESİ SB ENSTİTÜSÜ

Locations

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Alejandro LM, Behrendt CE, Chen K, Openshaw H, Shibata S. Predicting acute and persistent neuropathy associated with oxaliplatin. Am J Clin Oncol. 2013 Aug;36(4):331-7. doi: 10.1097/COC.0b013e318246b50d.

Reference Type: RESULT

PMID: 22547012 (View on PubMed)

Other Identifiers

Necmettin Erbakan University

Identifier Type: -

Identifier Source: org_study_id